CY1121791T1 - INNOVATIVE STABLE PHARMACEUTICAL FORM - Google Patents

INNOVATIVE STABLE PHARMACEUTICAL FORM

Info

Publication number
CY1121791T1
CY1121791T1 CY20191100705T CY191100705T CY1121791T1 CY 1121791 T1 CY1121791 T1 CY 1121791T1 CY 20191100705 T CY20191100705 T CY 20191100705T CY 191100705 T CY191100705 T CY 191100705T CY 1121791 T1 CY1121791 T1 CY 1121791T1
Authority
CY
Cyprus
Prior art keywords
pharmaceutical form
stable pharmaceutical
innovative
reconstituted
stable
Prior art date
Application number
CY20191100705T
Other languages
Greek (el)
Inventor
Carsten Olbrich
Thomas Trill
Original Assignee
Bayer Pharma Aktiengesellschaft
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Pharma Aktiengesellschaft filed Critical Bayer Pharma Aktiengesellschaft
Publication of CY1121791T1 publication Critical patent/CY1121791T1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Abstract

Η παρούσα εφεύρεση σχετίζεται με μια σταθερή φαρμακοτεχνική μορφή ιδιαιτέρως κατάλληλη για το ανοσοσύζευγμα MF-T-SPDB-DM4 έναντι της μεσοθηλίνης. Η περιγραφόμενη σταθερή υδατική φαρμακοτεχνική μορφή που περιλαμβάνει το MF-T-SPDB-DM4 είναι απευθείας κατάλληλη για θεραπευτικές εφαρμογές και για επακόλουθη λυοφιλίωση. Η λυοφιλιωμένη σκόνη μπορεί να ανασυσταθεί με νερό για να δημιουργηθεί ένα ανασυσταθέν διάλυμα που είναι και πάλι κατάλληλο για θεραπευτικές εφαρμογές. Ένας περαιτέρω στόχος είναι να παρασχεθεί μια σταθερή ανασυσταθείσα πρωτεϊνική φαρμακοτεχνική μορφή η οποία είναι κατάλληλη για θεραπευτικές χορηγήσεις.The present invention relates to a stable pharmaceutical form particularly suitable for the immunoconjugate MF-T-SPDB-DM4 against mesothelin. The described stable aqueous formulation comprising MF-T-SPDB-DM4 is directly suitable for therapeutic applications and for subsequent lyophilization. The lyophilized powder can be reconstituted with water to create a reconstituted solution that is again suitable for therapeutic applications. A further object is to provide a stable reconstituted protein formulation which is suitable for therapeutic administration.

CY20191100705T 2013-10-25 2019-07-03 INNOVATIVE STABLE PHARMACEUTICAL FORM CY1121791T1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13190276 2013-10-25
PCT/EP2014/072558 WO2015059147A1 (en) 2013-10-25 2014-10-21 A novel stable formulation
EP14786915.0A EP3060256B1 (en) 2013-10-25 2014-10-21 A novel stable formulation

Publications (1)

Publication Number Publication Date
CY1121791T1 true CY1121791T1 (en) 2020-07-31

Family

ID=49552164

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20191100705T CY1121791T1 (en) 2013-10-25 2019-07-03 INNOVATIVE STABLE PHARMACEUTICAL FORM

Country Status (15)

Country Link
US (2) US20160250349A1 (en)
EP (1) EP3060256B1 (en)
JP (1) JP6813355B2 (en)
CY (1) CY1121791T1 (en)
DK (1) DK3060256T3 (en)
ES (1) ES2735645T3 (en)
HR (1) HRP20191053T1 (en)
HU (1) HUE045020T2 (en)
LT (1) LT3060256T (en)
PL (1) PL3060256T3 (en)
PT (1) PT3060256T (en)
RS (1) RS58856B1 (en)
SI (1) SI3060256T1 (en)
TR (1) TR201909034T4 (en)
WO (1) WO2015059147A1 (en)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR076284A1 (en) 2009-04-29 2011-06-01 Bayer Schering Pharma Ag IMMUNOCONJUGADOS OF ANTIMESOTELINA AND USES OF THE SAME
HRP20220011T1 (en) * 2017-01-19 2022-04-01 Bayer Pharma Aktiengesellschaft Novel stable formulation for fxia antibodies
AU2018320470A1 (en) 2017-08-23 2020-02-13 Daiichi Sankyo Company, Limited Antibody-drug conjugate preparation and lyophilization for same
WO2020234114A1 (en) 2019-05-21 2020-11-26 Bayer Aktiengesellschaft A novel stable high concentration formulation for anetumab ravtansine
WO2023230098A1 (en) 2022-05-23 2023-11-30 Logicbio Therapeutics, Inc. Gene therapy compositions and methods of use thereof

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA009285B1 (en) * 2003-05-14 2007-12-28 Иммуноджен, Инк. Drug conjugate composition
NZ564843A (en) * 2005-08-03 2012-05-25 Immunogen Inc Immunoconjugate formulations comprising an immunoconjugate and an excipient in a buffered aqueous solution
TW200806315A (en) * 2006-04-26 2008-02-01 Wyeth Corp Novel formulations which stabilize and inhibit precipitation of immunogenic compositions
EP1854478A1 (en) * 2006-05-12 2007-11-14 Cytos Biotechnology AG Nicotine-carrier vaccine formulation
AR076284A1 (en) * 2009-04-29 2011-06-01 Bayer Schering Pharma Ag IMMUNOCONJUGADOS OF ANTIMESOTELINA AND USES OF THE SAME
JP2014515753A (en) * 2011-04-21 2014-07-03 バイエル・インテレクチュアル・プロパティ・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Novel binder-drug conjugates (ADC) and their use
CA2831572C (en) * 2011-05-02 2019-11-26 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
US20130004484A1 (en) * 2011-06-30 2013-01-03 Genentech, Inc. Anti-c-met antibody formulations

Also Published As

Publication number Publication date
HUE045020T2 (en) 2019-12-30
SI3060256T1 (en) 2019-08-30
US20160250349A1 (en) 2016-09-01
JP6813355B2 (en) 2021-01-13
DK3060256T3 (en) 2019-07-29
JP2016534062A (en) 2016-11-04
HRP20191053T1 (en) 2019-09-20
WO2015059147A1 (en) 2015-04-30
PT3060256T (en) 2019-07-19
LT3060256T (en) 2019-07-10
US20190240345A1 (en) 2019-08-08
ES2735645T3 (en) 2019-12-19
RS58856B1 (en) 2019-07-31
TR201909034T4 (en) 2019-07-22
PL3060256T3 (en) 2019-10-31
EP3060256B1 (en) 2019-05-08
EP3060256A1 (en) 2016-08-31

Similar Documents

Publication Publication Date Title
CY1121791T1 (en) INNOVATIVE STABLE PHARMACEUTICAL FORM
CY1123845T1 (en) TOPICAL MEDICINAL PREPARATION FOR THE TREATMENT OF INFLAMMATORY CONDITIONS
CY1124436T1 (en) BICYCLIC HETEROCYCLIC COMPOUNDS AND THERAPEUTIC USES THEREOF
CY1124998T1 (en) HETEROCYCLIC COMPOUNDS AND USES THEREOF
CY1121907T1 (en) ANTIDLL3-ANTISOMATO-PBD CONJUGATES AND USES THEREOF
CL2018001488A1 (en) Aqueous pharmaceutical formulation of the anti-pd-l1 avelumab antibody
AU2018256640A1 (en) Stabilized pharmaceutical formulations of insulin analogues and/or insulin derivatives
MA42950A (en) ADMINISTRATION OF MODIFIED CFTR POTENTIALIZATION AGENTS IN THE DEUTERIUM
CL2016000153A1 (en) Glioxamide substituted pyrrolamide derivatives and their use as medicines for the treatment of hepatitis b
EA201591004A1 (en) DERIVATIVES OF BORONIC ACID AND THEIR THERAPEUTIC APPLICATION
BR112015030514A2 (en) COMPOSITIONS AND METHODS FOR CONJUGATION OF ACTIVABABLE ANTIBODIES
CL2015003395A1 (en) Pyrazolopyrrolidine derivatives and their use in the treatment of disease
BR112014021325A2 (en) LIQUID PHARMACEUTICAL FORMULATION AND LYOPHILIZED FORMULATION
BR112018075140A2 (en) composition in the form of an injectable aqueous solution, and single dose formulation at a pH of 7 to 7.8
EA201790334A1 (en) Conjugates Anti-CDH6 Antibodies With Medicinal Products
MA44391A (en) COMBINATIONS OF ANTI-CD37 IMMUNOCONJUGATES AND ANTI-CD20 ANTIBODIES
ITMI20131693A1 (en) DERIVATIVES OF 1,4-CYCLOHEXYLAMINE AND THEIR PREPARATION
AR098168A1 (en) STABLE FORMULATION OF GLULISINE INSULIN
CY1123366T1 (en) 8-AMINO-2-OXO-1,3-DIAZA-SPIRO-[4.5]-DECANE DERIVATIVES
TR201910866T4 (en) Combined preparations for cancer treatment.
CY1122882T1 (en) 3-(CARBOXYETHYL)-8-AMINO-2-OXO-1,3-DIAZA-SPIRO-[4.5]-DECANE DERIVATIVES
CY1119749T1 (en) USE COMPOSITION FOR HAIR & HAIR COLORING
CL2017000212A1 (en) Angiopoietin 4-like anti-protein antibodies and methods of use
CY1121105T1 (en) PHARMACEUTICAL FORM OF ATAZANAVIR AND COMBISSTATIS FOR HIV TREATMENT
DK3411008T3 (en) Compositions comprising active sunscreens with polyhydroxyfullerene